ProClinical is partnering with a leading biotechnology company that develops novel oncology therapeutics. Based in Switzerland, the organisation is seeking a Vice President, Head of EU Medical Affairs - Oncology to join their team. The company is currently developing three clinical stage product candidates, making this a perfect opportunity to bring expertise and capability to this exciting and innovating company.
The Head of EU Medical Affairs will set up and provide the strategic direction for the Region Europe medical department and, in the future, will have overall responsibility for European affiliate Medical activities, including medical tactics and operations for all company products in our related disease areas. They will also support and ensure the company Medical department vision of maintaining a best-in-class medical function to provide services in alignment with the best governance and performance principles in the best interest of patients, Health Care Providers (HCP), and the company.
Job Responsibilities:
- Establishing the scientific reputation of the company in the European region; developing strong peer-to-peer scientific partnerships with thought leaders in alignment with overall company strategy.
- Providing leadership to the Medical Affairs team, including providing best-practice sharing across countries, therapeutic areas, products, etc.
- Leading, motivating, and enhancing the performance of the Medical Affairs team through direct reports to achieve agreed objectives.
- Agreeing contracts and processes in place with outsource partners.
- Leading the development of the regional medical plan aligned with global plans while aligning with the management team, including Access & Reimbursement, Marketing, and Sales and Regulatory affairs.
- Establishing and executing a coherent regional business plan that addresses patient needs.
- Identifying measurable goals to ensure execution of medical affairs plans.
- Identifying the needs for, and leading, REQ Projects in close collaboration with cross-functional teams and clinics/HCPs.
- Developing and managing budgets for medical activities and providing input into the medical affairs budgeting and planning process.
- Ensuring appropriate training as required to all business/affiliate colleagues on brands and diseases.
- Ensuring timely, accurate, and appropriate responses to all medical enquiries.
- Partnering and collaborating with Commercial and Access & Reimbursement to demonstrate medical value of company products relevant to local external stakeholders (payers, HCPs, agencies).
- Providing input to clinical trials (pre and post-marketing), developing and executing phase IVs, registries, etc. (master real-life medicine).
- Acting as a partner for R&D & Clinical Operations for pipeline and new products.
- Supporting regulatory strategies for registration of new products by providing local expertise.
- Ensuring compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical activities.
- Ensuring the consistent application of company internal standards and local regulations in medical affairs, including those related to promotional material, medical and scientific relations, and medical information.
- Sponsoring audits/inspections under Medical Director accountability.
- Providing support for audits on PV and regulatory.
- Acting as the responsible person for medical information and promotion in the European region.
- Ensuring the appropriate review of all promotional and educational materials, including compliance with the local and international rules, regulations, company internal SOPs, Product Licenses, and SmPC's;
Skills and Requirements:
- At least an MD with clinical experience, though a PhD is a preferred, but non-mandatory, advantage.
- A course in Pharmaceutical Medicine.
- At least 5 years of biotechnology/pharma industry experience.
- Demonstrable knowledge of local health care system/market dynamics, regulations, policies, and SOPs.
- A strategic approach to implementing scientific communication programs on disease areas and treatments.
- Demonstrated ability to build & lead a team and develop a high performing organisation and experience in leading medical teams and departments.
- Extensive knowledge of all aspects of drug development, GCP, and local regulations, including regulations of promotional materials; familiarity with global regulations.
- Experience in Marketing Authorization Application (MAA) processes for new drug application.
- Extensive knowledge of clinical trial design statistics and pharmacokinetics.
- Experience from involvement in reimbursement applications.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Director level.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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